Palatability of different urea oral formulations used in the treatment of low blood sodium levels
| ISRCTN | ISRCTN18369035 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18369035 |
| Secondary identifying numbers | CLAB/01/2023 |
- Submission date
- 23/06/2023
- Registration date
- 26/06/2023
- Last edited
- 07/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aim
Hyponatremia (when the sodium level in the blood is below normal) is the most common disorder of electrolytes encountered in clinical practice. HN is associated with illness and death, so it is important to identify treatments for these patients. Oral urea represents an effective, safe, and well-tolerated approach to the management of chronic hyponatremia. Oral urea is commonly prepared as a galenic formulation that is usually associated with distaste problems. The aim of this study is to compare the palatability of two different urea formulations: a commercial urea formulation and a galenic one.
Who can participate?
Healthy volunteers aged 50 to 60 years old
What does the study involve?
Participants are randomly allocated to consume the urea formulation A or B twice a day away from meals, solubilizing the products in 125 ml of water (T0). After a 3-day break, participants swap over and consume the other formulation twice a day away from meals. After the consumption of products, both in the morning and in the evening, participants complete a specific questionnaire to evaluate their palatability.
What are the possible benefits and risks of participating?
The study aims to identify a urea formulation with good taste to improve adherence to the therapy in patients with chronic hyponatremia. No specific risks are expected.
Where is the study run from?
Eurofins Cosmetics & Personal Care Italy S.r.l (Italy)
When is the study starting and how long is it expected to run for?
April 2023 to May 2023
Who is funding the study?
Difa Cooper SPA (Italy)
Who is the main contact?
Dr Massimo Milani, massimo.milani@difacooper.com
Contact information
Public
Via Milano 160
Caronno Pertusella
21042
Italy
 ORCID ID |
0000-0001-7559-1202 |
|---|---|
| Phone | +39 (0)29659031 |
| massimo.milani@difacooper.com |
Public
Via Milano 160
Caronno Pertusella
21042
Italy
| ORCID ID |
0000-0002-8099-0192 |
|---|---|
| Phone | +39 (0)29659031 |
| francesca.colombo@difacooper.com |
Study information
| Study design | Monocentric randomized double-blind two-arm cross over clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact detail to request a patient information sheet |
| Scientific title | Palatability of two different formulations of urea for the treatment of hyponatremia: a double-blind, cross-over study |
| Study acronym | UrHyp |
| Study objectives | The aim of this study was to evaluate, in a panel of healthy human subjects, the palatability of two different urea formulations: a commercial formulation (Food for Special Medical Purposes) was compared to a galenic one. |
| Ethics approval(s) |
Approved 26/04/2023, Internal Revision Committee of Cosmetics & Personal Care Italy Srl (via Bruno Buozzi, 2, Vimodrone (MI), 20055, Italy; +39 (0)2 25 071 51; InfoCosme@eurofins.com), ref: STUN723AA0075 |
| Health condition(s) or problem(s) studied | Hyponatremia |
| Intervention | The study evaluated the palatability of two urea formulations and was divided into two cross-over phases. Each participant consumed formulation A or formulation B twice a day away from meals, solubilizing the products in 125 mL of water (T0). After 3 days of wash-out (T1-T3, discontinuation of product intake), the formulations were cross-over and consumed twice a day away from meals (T4). Participants were randomized to consume a commercial urea formulation (Food for Special Medical Purposes, UREAL NM, Cantabria Labs, Difa Cooper, Caronno Pertusella, Italy) and a galenic urea formulation. The randomization list was generated by a dedicated computer program. The commercial urea formulation contains urea, flavouring, dextrose, sweeteners: sucralose, aspartame, acidifier: citric acid; the galenic formulation contains only urea. Participants consumed 7 g of each product (formulation A or formulation B) twice daily, solubilized in 125 ml of water. |
| Intervention type | Other |
| Primary outcome measure | Product palatability measured using a questionnaire modified from IJpma et al (2016) filled in by the test subjects after each intake on T0 and T4 |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 10/04/2023 |
| Completion date | 02/05/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 36 |
| Key inclusion criteria | 1. Age 50-60 years 2. 50% female and 50% male 3. Non-smokers |
| Key exclusion criteria | 1. Personal history of taste disorders 2. Presence of conditions capable of altering the sense of taste |
| Date of first enrolment | 27/04/2023 |
| Date of final enrolment | 27/04/2023 |
Locations
Countries of recruitment
- Italy
Study participating centre
Vimodrone (MI)
20055
Italy
Sponsor information
Industry
Via Milano 160
Caronno Pertusella
21042
Italy
| Phone | +39 (0)2 9659031 |
|---|---|
| stefano.fatelli@difacooper.com | |
| Website | http://www.difacooper.com/ |
"ROR" |
https://ror.org/044sr7e96 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | The future publication plan is to submit the results to a peer-reviewed high impact factor journal |
| IPD sharing plan | The dataset generated during the current study will be available upon request from Dr Francesca Colombo (francesca.colombo@difacooper.com). The final study report and raw data of all participants could be available on request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 09/11/2023 | 07/12/2023 | Yes | No |
Editorial Notes
07/12/2023: Publication reference added.
26/06/2023: Study's existence confirmed by the Eurofins Cosmetics & Personal Care Italy S.r.l..
